Medical balloons have been used in a number of different medical applications. One such application is balloon angioplasty in which a balloon is used to dilate a vessel. A balloon angioplasty procedure may be carried out simply by expanding a medical balloon in a vessel in order to compress plaque in a vessel.
Another such application is brachytherapy. A brachytherapy device is typically a low pressure (less than about 6 atmospheres) dilating balloon catheter that is used to center a radiation source wire in an artery. Brachytherapy devices are not commonly used to dilate an artery stenosis.
Yet another such application is balloon expansion of a prosthetic device such as a stent, graft, stent-graft and similar prosthetic devices.
As the use of balloon catheters has proliferated, there has been a proliferation in balloon catheter designs. Nevertheless, there remains a need for novel balloon catheters for use in procedures ranging from angioplasty, to brachytherapy to prosthetic expansion.
All U.S. patents and patent applications and all other published documents mentioned anywhere in this application are incorporated herein by reference in their entirety.
The invention in various of its embodiments is summarized below. Additional details of the invention and/or additional embodiments of the invention may be found in the Detailed Description of the Invention below.
The instant invention is directed, in one embodiment, to a medical device comprising a balloon with at least one expandable diaphragm disposed therein. The device comprises an inner tube having a proximal portion and a distal portion and an outer tube disposed about at least a portion of the inner tube. The outer tube has a proximal portion and a distal portion. A balloon having a proximal end and a distal end is disposed about the inner tube. The proximal end of the balloon extends from the distal end of the outer tube. A first expandable diaphragm having a first end and a second end is attached to the inner tube at the first end, interior to the balloon. The device further comprises a retractable sheath disposed about the inner tube. The retractable sheath is retractable from a first position in which it is disposed about at least a portion of the first expandable diaphragm to a second position in which the retractable sheath is axially displaced from the first diaphragm. On retraction of the retractable sheath, the first diaphragm expands to sealingly contact the interior of the balloon in a first contact region and form at least two compartments. The device also comprises a first inflation lumen in fluid communication with the balloon. Desirably, the device will comprise at least two expandable diaphragms.
In another embodiment, the invention is directed to a balloon assembly with a variable number of compartments. The balloon assembly comprises a balloon catheter comprising an inflatable medical balloon and M expandable diaphragms disposed within the balloon where Mxe2x89xa71. Each diaphragm is expandable from a first position in which the diaphragm does not sealingly contact the balloon to a second position in which the diaphragm sealingly contacts the balloon. The balloon has at least M+1 compartments when the M expandable diaphragms are all in the second position. Desirably, M equals 2 or 3.
The invention is also directed to a medical balloon transformable from a first configuration to a second configuration. In the first configuration, the medical balloon has a first number of internal compartments. In the second configuration, the medical balloon has more internal compartments than in the first configuration.
In yet another embodiment, the invention is directed to a method of forming a sub-divided balloon in a bodily vessel. The method comprises the steps of providing a medical device in accordance with the instant invention, inserting at least a portion of the medical device in a bodily vessel, delivering the medical device to a desired bodily location, retracting the retractable sheath and allowing the at least one expandable diaphragm to expand so as to sealingly contact the balloon and sub-divide the balloon into compartments and inflating the balloon.
In another embodiment, the invention is directed to a medical device comprising a catheter tube, a plurality of balloon elements disposed about the catheter tube, an inflation lumen having a plurality of inflation ports therein and a movable sheath disposed about the inflation lumen. Each balloon element is disposed about at least one inflation port. The movable sheath has at least one opening therein and is movable such that each balloon element may be placed in fluid communication with the inflation lumen by moving the movable sheath to align an opening in the movable sheath with the inflation port about which the balloon element is disposed.
In another embodiment, the invention is directed to a medical device comprising a catheter tube, a balloon disposed about the catheter tube, an inflation lumen having an inflation port therein and a movable sheath disposed about the inflation lumen. The movable sheath has at least one opening therein and is movable from an open position in which the opening in the movable sheath is at least partially aligned with the inflation port to a closed position in which the opening in the sheath is displaced from the infusion port.
The invention is also directed to a medical device comprising a catheter tube, an outer medical balloon disposed about the catheter tube and a serpentine medical balloon winding about the catheter tube and disposed within the outer medical balloon. A first inflation lumen is in fluid communication with the outer medical balloon and a second inflation lumen is in fluid communication with the serpentine medical balloon. Optionally, the medical device may comprise a plurality of serpentine medical balloons disposed within the outer medical balloon and winding about the catheter tube. The serpentine medical balloons may be supplied by a single inflation lumen. The invention also allows for each serpentine medical balloon to be supplied by a separate inflation lumen.
The invention is also directed to a medical device comprising a catheter tube, an outer medical balloon disposed about the catheter tube and one or more serpentine medical balloons disposed within the outer medical balloon. Each serpentine medical balloon winds about the catheter tube. The medical device further comprises an inflation device for inflating the outer medical balloon and each of the serpentine medical balloons.
The invention is also directed in another embodiments to a method of centering a catheter tube within a medical balloon. An inventive medical device comprising a serpentine balloon winding about a catheter is provided. The serpentine balloon is disposed within an outer balloon. An inflation fluid is supplied to the outer medical balloon and to the one or more serpentine balloons to center the inner tube.
The invention is also directed a method of dilating a stenosis and treating the stenosis with radiation. The method comprises the steps of inserting at least a portion of a brachytherapy device in a bodily vessel, advancing the brachytherapy device to a desired bodily location, expanding the outer medical balloon, expanding the serpentine medical balloon and advancing the radiation source through the inner tube to the stenosis. The brachytherapy device comprises a catheter tube with an outer medical balloon disposed about the catheter tube, a serpentine medical balloon winding about the catheter tube within the outer medical balloon and a radiation source.
The invention is also directed to a medical device comprising a catheter tube, at least one spiral medical balloon wound about the catheter tube, the spiral medical balloon characterized by a pitch which may be varied and an inflation lumen in fluid communication with the spiral medical balloon. The medical device further comprises a balloon moving device which is capable of compressing the spiral medical balloon to increase the pitch of the spiral medical balloon.
A detailed description of the invention in its various embodiments is provided below.